BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEPARIN COATED LUMINAL PACING CATHETER

    K Number: K875337 · Decision May 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    13
    Review Days
    147

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    Basic Information

    Device Name
    HEPARIN COATED LUMINAL PACING CATHETER
    K Number
    K875337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Spectramed, Inc.
    Date Received
    December 30, 1987
    Decision Date
    May 25, 1988
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Spectramed, Inc.

    K Number Device Name
    K896122 AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED
    K892941 CCO SYSTEM MODEL SP1467,SP5567,SP6267
    K895323 MODEL DT-BAL, BALANCE SAVER
    K894362 MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP
    K881857 AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.
    K885235 SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.
    K881825 MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
    K880740 MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
    K873168 SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
    K871573 CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS
    Search all 13 clearances from Spectramed, Inc. →